Package Leaflet: Information for the Patient

Bilastina Teva 20 mg Buccodispersible TabletsEFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Bilastina Teva is and what it is used for

2.What you need to know before you start taking Bilastina Teva

3.How to take Bilastina Teva

4.Possible side effects

5Storage of Bilastina Teva

6.Contents of the pack and additional information

Bilastina Teva contains bilastine as the active ingredient, which is an antihistamine.

Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, itchy nose, nasal congestion, and red, itchy eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

Bilastina Teva 20 mg chewable tablets is indicated for adults and adolescents.

Do not take Bilastina Teva:

• if you or your child are allergic to bilastina or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bilastina Teva if you have moderate or severe renal insufficiency, low levels of potassium, magnesium, or calcium in the blood, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medications that can affect heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc prolongation in the electrocardiogram) that can occur in some forms of heart disease, or if you are taking other medications (see “Other medications and Bilastina Teva”).

Children

Do not administer this medication to children under 12 years old.

Other medications and Bilastina Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

In particular, inform your doctor if you are taking any of the following medications:

• Ketoconazole tablets (used to treat Cushing's syndrome, when the body produces an excess of cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (to treat chest pain or pressure - angina)
• Cyclosporine (to reduce the activity of your immune system, and thus prevent transplant rejection or reduce the activity of autoimmune and allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (to treat AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Teva with food, drinks, and alcohol

These buccal tablets should not be taken with food or with grapefruit juice or other fruit juices, as this would decrease the effect of bilastina. To avoid this, you can:

• take the buccal tablet and wait one hour before eating or taking fruit juices, or
• if you have eaten or taken fruit juices, wait for two hours before taking the buccal tablet.

Bilastina, at the recommended dose in adults (20 mg), does not increase the drowsiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or these are very limited on the use of bilastina in pregnant women and during breastfeeding, and on the effects on fertility.

If you are pregnant or breastfeeding, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

It has been demonstrated that bilastina 20 mg does not affect performance during driving in adults.

However, the response of each patient to the medication may be different.

Therefore, check how this medication affects you before driving or operating machinery.

Bilastina Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per buccal tablet; this is, essentially “sodium-free”.

Bilastina Teva contains sulfur dioxide

This medication contains sulfur dioxide and, rarely, may cause severe hypersensitivity reactions and bronchospasm.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed by your doctor or pharmacist.Consult your doctor or pharmacist again if you are unsure.

The recommended dose in adults, including elderly patients and adolescents 12 years of age and older is 20 mg once a day.

Use in children

For children aged 6 to 11 years with a minimum body weight of 20 kg, there are other more suitable pharmaceutical forms of this medication available – bilastine 10 mg buccal dispersible tablets or bilastine 2.5 mg/ml oral solution.

Consult your doctor or pharmacist.

Do not administer this medication to children under 6 years of age with a body weight less than 20 kg as there are insufficient data available.

Since the duration of treatment will be determined by your doctor, they will also determine the type of disease you have and for how long you should take Bilastina Teva.

If you take more Bilastina Teva than you should

If you, or anyone else, exceed the dose of this medication, inform your doctor immediately or visit the nearest hospital emergency department. Please remember to bring this medication packaging or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Bilastina Teva

Do not take a double dose to compensate for the missed dose.

If you forget to take the daily dose on time, take it as soon as possible and then return to the usual dosing schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you interrupt treatment with Bilastina Teva

Generally, there will be no effects after abandoning treatment with Bilastina Teva.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experienceallergic reactions whose symptoms may include difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin, seek medical attention immediately and stop taking this medicine.

Side effects that may appearin adults and adolescents:

Common: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

• electrocardiogram alterations
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (urge to vomit)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (a sensation of spinning or dizziness)
• weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• fever (cold sore)
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increased blood fats

Frequency unknown: cannot be estimated from available data

• palpitations (feeling heartbeats)
• tachycardia (rapid heartbeats)
• vomiting

Other side effects that may appearin children:

Common: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain/upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (urge to vomit)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on thecontainerand on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the Sigre Point of the pharmacy.In case of doubtask your pharmacisthow to dispose ofthecontainers and medicines you no longerneed.This will help protect the environment.

Composition of Bilastina Teva

• The active ingredient is bilastina.

Each tablet contains 20 mg of bilastina.

• The other componentsare:

Manitol, microcrystalline cellulose, sodium croscarmellose (see section 2 "Bilastina Teva contains sodium"), aluminum magnesium metasilicate, sucralose, grape flavor (see section 2 "Bilastina Teva contains sulfur dioxide"), magnesium stearate, anhydrous colloidal silica.

Appearance of the product and content of the container

Bilastina Teva 10 mg buccal tablets EFG are oval-shaped tablets of approximately 10.3 x 5.5 mm, white to off-white in color, smooth to speckled, biconvex, engraved with "20" on one side and smooth on the other side.

The tablets are packaged in blisters of 10, 20, 30 or 50 tablets.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5, 2031GA Haarlem

Netherlands

Responsible for manufacturing:

Saneca Pharmaceuticals a.s.

Nitrianska 100 920 27 Hlohovec

Slovak Republic

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1st floor

28108 Alcobendas – Madrid (Spain)

Last review date of thisleaflet:March 2025

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)